Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In patients with metastatic clear-cell renal cell carcinoma, the combination of lenvatinib and pembrolizumab has shown activity. This phase 2 trial first gives all eligible participants 12 weeks of therapy, then randomizes those with stable disease to receive either SBRT to up to three lesions in addition to the standard drugs or the drugs alone. The primary endpoint is the objective response rate of unirradiated lesions after randomization, with secondary aims including safety and overall outcomes. The study is multicenter and supervised by a multidisciplinary team to select irradiation targets. Eligible participants have measurable disease, no prior systemic therapy for metastasis, and good performance status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Histologically confirmed clear-cell renal cell carcinoma.
* Presence of measurable lesions per RECIST 1.1.
* Sum of diameters of target lesions ≤ 7 cm.
* ECOG 0-2.
* No prior systemic therapy for metastatic disease.

Exclusion Criteria:

* Uncontrolled comorbidities that preclude the use of TKI/IO or SBRT.
* Prior SBRT to the lesions planned for irradiation, rendering re-irradiation unsafe.
* Active autoimmune diseases requiring systemic immunosuppressants.
* Symptomatic CNS metastases (patients with asymptomatic metastases may be included).

Where it's running

• Republican Dispensary of Tatarstan
  Kazan', Russia Recruiting
• N.N. Blokhin National Medical Research Center of Oncology
  Moscow, Russia Recruiting
• STOONCO clinic
  Moscow, Russia Recruiting
• Orenburg Regional Cancer Center
  Orenburg, Russia Recruiting
• SBHI Leningrad Regional Clinical Hospital
  Saint Petersburg, Russia Recruiting
• Cancer Center "Medical City"
  Tyumen, Russia Recruiting

Study contacts

• Study coordinator: Ilya Tsimafeyeu
• Email: sten_to@mail.ru
• Phone: +74999054690

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.